To support the increasing compliance and data integrity demands Team are recruiting a Senior Quality Engineer. Working with a portfolio of varied and exciting projects, this role will support the implementation of and adherence to our quality management systems.
Success in the role will require collaboration within multidisciplinary medical device development project teams, as well as collaboration with clients and Quality Assurance counterparts in client organisations.
- Ensuring compliance to Team’s QMS / Client QMS and agreed standards
- Mentoring the project team in the implementation of the QMS
- Facilitating the pragmatic application of the quality management system within projects. This includes:
- Reviewing and approving project documentation
- Ensuring traceability of goods on clients projects
- Working closely with Project Administrators for the maintenance of project documentation register, and documentation and preparation of elements of DHF/Technical Files
- Supporting Team QA during third party audits
- Willingness to travel occasionally including internationally
Qualifications & skills
- HND in quality or relevant degree, e.g. in engineering or science
- A minimum experience of 5 years in combination drug delivery and medical device product development
- Experience of project quality management
- Experience of working in a project based organisation
- Demonstrable experience in quality assurance
- Experience of creating and managing elements of a Design History File / Technical File
- Knowledge of ISO 13485, FDA QSR and Medical Device Directive
- Knowledge of other QMS; ISO 62366 and 62304
- Eagerness to learn new skills and a commitment to continuous professional development
- Awareness of industry trends and developments
- Worked in a consulting environment
Leadership/ Consultancy Skills
- Excellent communication skills
- Excellent analytical ability - data gathering, analysis and presentation of conclusions to the team
- Ability to liaise with colleagues, clients and sub-contractors at technical and non-technical levels, as well as all levels of seniority
- Ability to build and sustain productive working relationships with colleagues
- Commitment to quality and excellent attention to detail
- Calm under pressure
- Project management
- Structured and methodical problem solving
- Collaborative and actively shares own knowledge
- A track record of continuous learning and of driving best practice
- Enthusiastic with a positive outlook
- Self-sufficient and willing to take responsibility for own tasks
- Shows integrity and honesty at all times
- Respectful of others opinions and contributions, and supportive of colleagues
- Collaborates effectively and is a good team player, including being aware of own limitations and the strengths of others
Team values equality, diversity and inclusion in employment and recruitment. We are committed to promoting equal opportunities and an inclusive community, where our talented people respect and value the contributions, skills, and abilities of others.
We want our people to succeed on merit, treating individuals equally, including making decisions and providing encouragement and opportunities relating to recruitment, career development and retention in a fair and consistent manner.
Our aim is a workplace free from all forms of bullying, harassment or victimisation, and unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief, and marriage and civil partnerships.